Participant Information Sheet 1 This is important information to help you decide whether to donate a sample for health and medical research. You have been given this information because you are being asked to: donate a sample to the NSW Health Statewide Biobank, and give permission for NSW Health to collect and link your health and personal information (data) to the sample now and into the future. You can find more information in our Frequently Asked Questions at biobank.health.nsw.gov.au/participants 2 You have been asked to donate a sample to support health and medical research. Researchers use human samples to learn about illness and find better ways to help people with health problems. Your donation will support research that may result in discoveries that can change, improve and save the lives of others in the future. 3 If you choose to donate a sample, it will be used in research studies. A sample could be any of the below items: Blood Saliva Urine Stool/Poo Bone Breast milk Tissue taken from your body by a healthcare professional (skin, part of an organ or tumour or other cells from your body). biobank.health.nsw.gov.au 1
Transcript
Participant Information Sheet
1 This is important information to help you decide whether to donate a sample for health and medical research.
You have been given this information because you are being asked to:
donate a sample to the NSW Health Statewide Biobank, and
give permission for NSW Health to collect and link your health and personal information (data) to the sample now and into the future.
You can find more information in our Frequently Asked Questions at biobank.health.nsw.gov.au/participants
2 You have been asked to donate a sample to support health and medical research.
Researchers use human samples to learn about illness and find better ways to help people with health problems.
Your donation will support research that may result in discoveries that can change, improve and save the lives of others in the future.
3 If you choose to donate a sample, it will be used in research studies.
A sample could be any of the below items:
Blood Saliva Urine Stool/Poo Bone Breast milk Tissue taken from your body by a healthcare professional
(skin, part of an organ or tumour or other cells from your body).
4 Your sample will be stored safely in the NSW Health Statewide Biobank.
A biobank is a secure place for storing human samples.
Samples stored in the Biobank are used for ethically approved health and medical research. They help researchers find better ways to detect and treat illness and disease.
Like a bank, samples donated for health and medical research are kept under tight security and in carefully controlled conditions.
5 It is your choice to donate or not.
Choosing to donate a sample for health and medical research is voluntary. You should talk to your doctor, family or friends before you decide.
6 Your decision will not affect your care or treatment in any way.
Donating a sample is not part of your routine medical treatment or healthcare.
7 You can choose to stop taking part at any time.
If you choose to donate a sample, but change your mind later, that is ok. The decision will not affect your medical treatment or healthcare in any way.
If you choose to stop taking part, the samples you donated would be removed from the biobank and safely destroyed. Your health information, held in the biobank, will be deleted.
Some or all of your sample might have already been given to a researcher and used for a study. They will be asked to destroy this sample.
If you choose to stop taking part, contact the NSW Health Statewide Biobank.
your doctor your nurse other people in your healthcare team, or the person who gave you this information sheet and is
asking for your consent.
You can also contact the NSW Health Statewide Biobank. They are in charge of safely storing samples and health and personal information (data) to support health and medical research.
9 Your sample will be linked with your health and personal information (data).
If you choose to donate a sample for health and medical research, it will be linked to health and personal information (data) held by the NSW and Commonwealth governments and by researchers.
This brings together lots of information about you and might include details about:
your diagnosis, for example operation and test results the times you go to the emergency department or had to
stay in hospital the times you go to the family doctor (based on Medicare
Benefits Schedule claims) the prescription medicines you get from a pharmacy
(based on Pharmaceutical Benefits Scheme claims) your personal information, such as your education,
employment and lifestyle research that is done on your sample.
This information helps researchers better understand your health and might help develop future treatments and even cures for diseases.
With your permission, this information from the NSW and Commonwealth governments and researchers will be electronically linked to your sample. Information will be stored securely without your name and contact details and used only for approved health and medical research.
10 Your name and address is removed from your sample.
Personal information, such as your name and address, is replaced with a unique number before we share it with approved researchers.
In rare cases, researchers might identify you from your information. If this happens, researchers are required by law to maintain your privacy and report any breaches to the relevant ethics committee/ privacy officers.
11 Your health and personal information (data) will be stored securely.
Your information is stored using strict security and privacy protocols and in line with legal and ethical requirements.
It may be stored for an unlimited period of time, but is only released to researchers for ethically approved health and medical research.
12 Your sample and health and personal information (data) might be used for a range of different health or medical research studies, now and in the future.
This could include:
research into the cause, prevention, diagnosis and treatment of disease
finding a cure or new treatment for a condition such as cancer, diabetes or dementia
research into genetic or rare conditions clinical trials (an organised test of medicines and new
treatments involving patients and volunteers) the study of human populations, or monitoring new treatments or medicines over time.
Your sample and information can only be used in projects that have been reviewed and approved by a registered Human Research Ethics Committee. This committee checks that projects are ethically acceptable. This means that the research respects and protects you and the other people who have donated samples.
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13 (data) can be used by approved research studies in NSW, Australia and around the world.
It is common for health and medical researchers to work together with researchers in other states or even overseas. This can help speed up the time it takes to get findings from research labs into clinics to help patients.
All research studies must be approved by a Human Research Ethics Committee that meets international ethical standards. All researchers will be screened.
14 You won’t be told what research studies your sample is used for.
We won’t tell you when or where researchers use your sample for a research study.
All research projects that use donated samples and health and personal information (data) will be listed on the NSW Health Statewide Biobank website, biobank.health.nsw.gov.au.
15 You won’t be paid for your donation.
Your choice to contribute a sample and provide your health and personal information (data) is a donation.
16 Your sample could be held forever.
Or until you choose to stop taking part.
If you are giving permission for your child to donate, we will contact you again when they turn 14 and your child when they turn 18. We will ask you and the child for permission to keep storing the sample and health and personal information (data).
17 Your privacy will be secure and protected.
Your health and personal information (data) will be kept secure and confidential. If a breach of privacy happens, it will be dealt with in line with privacy laws and guidelines.
In very rare cases, we may have a legal obligation to make your information available to parties outside of NSW Health who are not approved researchers. For example, in the case of a new infectious disease that could affect other people both you and other parties would be informed.
18 During research, discoveries could be made that have serious and important health consequences for you or your family.
When testing your sample, researchers may find that you or your family members might be at risk of a serious health condition. For example, a gene for sudden heart attack, a type of cancer or other life-threatening condition that can be treated.
It is very rare for a serious finding to be discovered. If this happens, your nominated doctor or healthcare professional will contact you to tell you that a potential serious finding might exist and you will be referred to a medical expert or genetic councillor. They will only contact you if the finding is significant, confirmed and can be treated. General or non-specific health information such as evidence of a risk of high cholesterol, would not be returned to you.
If you are not contacted about a finding, it does not mean you don’t have any health issues. Researchers do not perform general testing on your sample. It is important to continue your regular health check-ups with your family doctor and other health professionals.
If a serious finding is made and you are told about it, it might have an effect on any insurance you apply for in the future (for example life insurance or income protection). We suggest you get advice from your chosen insurer.
19 There are times we will need to contact you.
a. A person from the NSW Health Statewide Biobank may contact you by phone to confirm that you have given consent. This phone call will be recorded and kept as a legal record.
b. The Collection Custodian, if you are a child who turns 14 or 18, to be re-consented.
c. Your doctor or healthcare professional will contact you if a serious finding is discovered that has health implications for you or your family.
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20 You are being asked to give your consent to:
a. Donate samples to the NSW Health Statewide Biobank for ethically approved health and medical research.
b. Have your sample linked to health and personal information (data) held by the NSW and Commonwealth governments and by researchers.
c. Have your sample and health and personal information (data) stored securely and used for ethically approved health and medical research now and into the future.
CONTACT
If you have questions, concerns or feedback, or if you would like more information, please contact the Human Research Ethics Committee that approved the study (listed on your Participant Information Sheet Cover Page).
Please keep a copy of this information sheet, along with your signed consent form.
